Search by Drug Name or NDC

NDC 70719-0003-01 Heilen 6; 6; 6; 6; 30; 12; 6; 3; 12; 200; 12; 12; 12; 30; 30; 30; 12; 12; 30; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Heilen 6; 6; 6; 6; 30; 12; 6; 3; 12; 200; 12; 12; 12; 30; 30; 30; 12; 12; 30; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Heilen is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Heilen. The primary component is APIS MELLIFERA; CAPSICUM; CHASTE TREE FRUIT; CHELIDONIUM MAJUS WHOLE; COLCHICUM AUTUMNALE BULB; DIBASIC POTASSIUM PHOSPHATE; FUCUS VESICULOSUS; GALIUM APARINE WHOLE; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBA.

Product Information

NDC	70719-0003
Product ID	70719-0003_5b132501-f52a-410c-b606-b6142568bcd1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Heilen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Galium Aparine, Agnus Castus, Apis Mellifica, Capsicum Annuum, Chelidonium Majus, Taraxacum Officinale, Urtica Dioica, Xanthoxylum Fraxineum, Fucus Vesiculosus, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum, Sarsaparilla (smilax Regelii), U
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	6; 6; 6; 6; 30; 12; 6; 3; 12; 200; 12; 12; 12; 30; 30; 30; 12; 12; 30; 6; 12; 6; 6
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	APIS MELLIFERA; CAPSICUM; CHASTE TREE FRUIT; CHELIDONIUM MAJUS WHOLE; COLCHICUM AUTUMNALE BULB; DIBASIC POTASSIUM PHOSPHATE; FUCUS VESICULOSUS; GALIUM APARINE WHOLE; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBA
Labeler Name	Heilen
Pharmaceutical Class	Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased His
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70719-0003-01 (70719000301)

Pricing Information	N/A
NDC Package Code	70719-0003-1
Billing NDC	70719000301
Package	30 mL in 1 BOTTLE, DROPPER (70719-0003-1)
Marketing Start Date	2022-01-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ef3f66f9-47bc-4fce-8950-ed2319bc30d6 Details

ACTIVE INGREDIENTS:

Galium Aparine 3X, Agnus Castus 6X, Apis Mellifica 6X, Capsicum Annuum 6X, Chelidonium Majus 6X, Taraxacum Officinale 6X, Urtica Dioica 6X, Xanthoxylum Fraxineum 6X, Fucus Vesiculosus 6X, 12X, 30X, Kali Phosphoricum 12X, Magnesia Phosphorica 12X, Natrum Phosphoricum12X, Sarsaparilla (Smilax Regelii) 12X, Ubidecarenonum 12X, Calcarea Carbonica 12X, 30X, 60X, Graphites 12X, 30X, 60X, Lycopodium Clavatum 12X, 30X, 60X, Anacardium Orientale 30C, Colchicum Autumnale 30C, Nux Vomica 30C, Phytolacca Decandra 30C, Pulsatilla (Pratensis) 30C, Histaminum Hydrochloricum 200C.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to increased appetite, regulation of fat metabolism, sluggish metabolism, headache, and fatigue.**

**These statements are based upon homeopathic principles. They have not been approved by the Food and Drug Administration.

WARNINGS:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: Sealed for Your Protection. Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

1-12 drops under the tongue, 3 times a day or as directed by your health professional. Avoid eating and/or drinking 15 minutes or longer before or after taking. Consult a physician for use in children under 12 years of age. Do not touch dropper to lips, teeth, or tongue to avoid contamination. Keep lid tightly closed when not in use.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to increased appetite, regulation of fat metabolism, sluggish metabolism, headache, and fatigue.**

**These statements are based upon homeopathic principles. They have not been approved by the Food and Drug Administration.

INACTIVE INGREDIENTS:

demineralized water, 20% ethanol

QUESTIONS:

Distributed by Heilen

Brentwood, MO 63144

888-305-1412 • www.goheilen.com

PACKAGE LABEL DISPLAY:

+plus

Heilen

HOMEOPATHIC FORMULA

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

HEILEN

galium aparine, agnus castus, apis mellifica, capsicum annuum, chelidonium majus, taraxacum officinale, urtica dioica, xanthoxylum fraxineum, fucus vesiculosus, kali phosphoricum, magnesia phosphorica, natrum phosphoricum, sarsaparilla (smilax regelii), ubidecarenonum, calcarea carbonica, graphites, lycopodium clavatum, anacardium orientale, colchicum autumnale, nux vomica, phytolacca decandra, pulsatilla (pratensis), histaminum hydrochloricum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70719-0003
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488)	GALIUM APARINE WHOLE	3 [hp_X] in 1 mL
CHASTE TREE FRUIT (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE FRUIT	6 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X] in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	6 [hp_X] in 1 mL
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS WHOLE	6 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	6 [hp_X] in 1 mL
URTICA DIOICA WHOLE (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46)	URTICA DIOICA WHOLE	6 [hp_X] in 1 mL
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T)	ZANTHOXYLUM AMERICANUM BARK	6 [hp_X] in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	6 [hp_X] in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	12 [hp_X] in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	12 [hp_X] in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	12 [hp_X] in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX ORNATA ROOT	12 [hp_X] in 1 mL
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46)	UBIDECARENONE	12 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X] in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	12 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 1 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU)	SEMECARPUS ANACARDIUM JUICE	30 [hp_C] in 1 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	30 [hp_C] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_C] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	30 [hp_C] in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI)	PULSATILLA PRATENSIS WHOLE	30 [hp_C] in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	200 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70719-0003-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/21/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/21/2022

Labeler - Heilen (080246141)

Revised: 1/2022

Document Id: 5b132501-f52a-410c-b606-b6142568bcd1

Set id: ef3f66f9-47bc-4fce-8950-ed2319bc30d6

Version: 1

Effective Time: 20220121

Search by Drug Name or NDC

Product Information

Package

Package Images

NDC 70719-0003-01 (70719000301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ef3f66f9-47bc-4fce-8950-ed2319bc30d6 Details

ACTIVE INGREDIENTS:

HOMEOPATHIC INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

HOMEOPATHIC INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?